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AEVI-007

Phase 1

Multiple Myeloma | Small molecule | Oncology |Avalo Therapeutics, Inc.|Last Updated: Feb 29, 2024

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment13

FDA Designations

No designations recorded

Clinical trial landscape

AEVI-007 · 1 trial · 1 indication

Phase 1 1
NCT04671251Phase 1b Study of AEVI-007 in Subjects With Relapsed or Refractory Multiple MyelomaMultiple Myeloma
COMPLETED13 Analytics
PHASE1COMPLETED
Phase 1b Study of AEVI-007 in Subjects With Relapsed or Refractory Multiple Myeloma
Multiple MyelomaUnlock trial analytics

Study Endpoints

Primary Endpoints

Recommended Phase 2 Dose
Cohorts 1-3 will take approximately 4-5 months

Identify the recommended Phase 2 dose based on safety, pharmacokinetics and pharmacodynamics observed in this Phase 1b study.

Secondary Endpoints

Incidence of Treatment Emergent Adverse Events (TEAEs)
Approximately 9 months
Incidence of Clinically Significant Changes in Clinical Laboratory Results
Approximately 9 months
Incidence of Clinically Significant Changes in Vital Signs
Approximately 9 months
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSEQUENTIAL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
AEVI-007EXPERIMENTALOpen-label, dose-escalation, single-arm

Interventions

NameTypeDescription
AEVI-007DRUG50 mg of AEVI-007 and will be reconstituted with 1.2 mL of water for injection.
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites7

Inclusion Criteria: 1. Subject has active R/R multiple myeloma. 2. Subject has measurable myeloma based on any of the following: * Serum M-protein \> 0.5 g/dL * Urine M-protein \> 200 mg/24 hours * Serum free light chains \> 10 mg/dL * Measurable plasmacytoma or extramedullary disease ...

Countries:United States
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Competitive Landscape -Multiple Myeloma 221 trials

Top 20 of 25 competitors

CompanyTickerTrialsLead PhaseDrugs
AbbVie, Inc.ABBV16PHASE3Pomalidomide, Dexamethasone, Venetoclax
Bristol-Myers Squibb CompanyBMY18PHASE3Iberdomide, Lenalidomide
Takeda Pharmaceutical Co. Ltd. Sponsored ADRTAK5PHASE3IGI, 10%
GSK plc Sponsored ADRGSK17PHASE3Belantamab mafodotin, Pomalidomide, Dexamethasone, Bortezomib
Johnson & JohnsonJNJ28PHASE3Talquetamab, Pomalidomide, Teclistamab, Elotuzumab, Dexamethasone
Regeneron Pharmaceuticals, Inc.REGN11PHASE3Linvoseltamab, Carfilzomib, Daratumumab, Dexamethasone, Pomalidomide
Pfizer Inc.PFE11PHASE3Elranatamab, Lenalidomide
Sanofi SA Sponsored ADRSNY17PHASE3Isatuximab, Dexamethasone, Pomalidomide, Montelukast, Paracetamol/ Acetaminophen
AstraZeneca PLCAZN5PHASE3AZD0120, Daratumumab, Carfilzomib, Dexamethasone, Bortezomib
Gilead Sciences, Inc.GILD3PHASE3Anitocabtagene Autoleucel, Cyclophosphamide, Fludarabine, Pomalidomide, Bortezomib
Karyopharm Therapeutics, Inc.KPTI6PHASE3Selinexor, Elotuzumab, Pomalidomide, Dexamethasone
Grifols, S.A. Sponsored ADR Class BGRFS1PHASE3Xembify
BioLineRX Ltd. Sponsored ADRBLRX1PHASE3BL-8040/kg, G-CSF
C4 Therapeutics, Inc.CCCC3PHASE2Cemsidomide, Dexamethasone
Cellectar Biosciences, Inc.CLRB1PHASE2Iopofosine I 131 single dose, Iopofosine I 131 fractionated dose
GeoVax Labs, Inc.GOVX1PHASE2COVID-19 Vaccine, Synthetic MVA-based SARS-CoV-2 Vaccine GEO-CM04S1
Autolus Therapeutics Plc Sponsored ADRAUTL1PHASE2AUTO CAR T cell therapy
Incyte CorporationINCY2PHASE1Ruxolitinib, Lenalidomide, Methylprednisolone
Moderna, Inc.MRNA2PHASE1mRNA-2808
BeOne Medicines Ltd. Sponsored ADRONC1PHASE1Sonrotoclax, Dexamethasone, Carfilzomib, Daratumumab, Pomalidomide
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Frequently asked questions about AEVI-007

What is AEVI-007 used for?

AEVI-007 is an investigational small molecule being developed for the treatment of multiple myeloma, a type of blood cancer. It is being studied in patients with relapsed or refractory multiple myeloma, meaning the disease has returned or has not responded to prior treatment.

Who is developing AEVI-007?

AEVI-007 is being developed by Avalo Therapeutics, Inc., a biopharmaceutical company traded on the Nasdaq under the ticker symbol AVTX. The company is conducting clinical research on this small molecule for the oncology indication of multiple myeloma.

What phase is AEVI-007 in?

AEVI-007 is in Phase 1 clinical development. A Phase 1b study of the drug in subjects with relapsed or refractory multiple myeloma has been completed. The drug is investigational and has not been approved by regulatory authorities.

What clinical trials is AEVI-007 in?

AEVI-007 has been studied in a completed Phase 1b clinical trial with the identifier NCT04671251. The trial enrolled 13 participants with relapsed or refractory multiple myeloma in the United States. The study was uncontrolled and did not use randomization or blinding.

Is AEVI-007 the same as any other drug?

AEVI-007 is the drug name used in clinical development for this investigational small molecule. No alternative names have been established in the available clinical trial information, and it is identified solely as AEVI-007 in the completed Phase 1b study.